The startup, which was founded by two Washington University researchers and a Wharton MBA, is looking to take a big bite out of Cologuard's market.
The assay's CE marking permits its use for the early diagnosis of HIV-1 in infants and for measuring viral load and disease progression using dried blood spot samples.
The FDA said it is the first test authorized to test for M. genitalium, a slow-growing bacteria that is difficult to detect with traditional laboratory methods.
The assay, which was CE marked last month, qualitatively detects group B Streptococcus nucleic acid from 18- to 24-hour Lim broth enrichments.
A diverse group of researchers and diagnostic industry participants has collaborated to produce two papers that describe and critique Lyme disease testing technologies.
Clinical research has shown that the assay exhibited 100 percent sensitivity compared to culture-based testing methods, Hologic said.
In Life Sciences, CEO Thomas Joyce noted a strong performance by Beckman Coulter, while in Diagnostics, he said Cepheid grew 25 percent year over year.
The agency updated its guidance for samples tested using nucleic acid testing, saying the technology has improved detection for the viruses.
The British-based firm says that its assay detects hepatitis C via a single-use, disposable cartridge within 90 minutes of testing.
The grant is specifically intended to support the development of noninvasive, rapid tests that can be used at the point of care in developing country settings.